Thursday, July 22, 2010

Yet Another Boston Scientific Defibrillator Advisory

Boston Scientific Corp. warned physicians that three of its implantable defibrillators have a defect that can prevent them from working properly, in the latest problem for the company's heart devices.

A magnetic switch on the implantable cardiac defibrillators can get stuck, stopping the devices from delivering an electric shock to the hearts of patients who need the therapy, the company said in a letter to doctors.

The Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs were made in 2006 and 2007, and about 34,000 remain implanted in patients, according to the Natick, Mass., company, which said on Thursday that it had issued the advisory.

It is unclear how Boston Scientific learned about the problem, and why it issued the advisory now. A company spokeswoman didn't immediately respond to requests for comment.

Boston Scientific said in its product advisory that the risk of harm was remote, and it hasn't received any reports of deaths or injuries. Doctors have replaced some of the devices, according to the advisory, but the company recommends against it.

The original physician communication, dated today, can be found in pdf format here.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.